1. Field of the Invention
The present invention relates generally to the treatment of anatomical tissue with high intensity focused ultrasound energy and, more particularly, to hand-held focused ultrasound ablation devices having handle shafts used to position ultrasound emitting members adjacent tissue to be treated and to methods of using the same.
2. Brief Description of the Related Art
When high intensity ultrasound energy is applied to anatomical tissue, significant physiological effects may be produced in the anatomical tissue resulting from thermal and/or mechanical changes or effects in the tissue. Thermal effects include heating of the anatomical tissue; and, when the tissue is heated to a sufficiently high temperature, tissue damage such as coagulative necrosis is produced. In order to produce thermal effects in anatomical tissue, ultrasound emitting members having ultrasound emitting elements, such as transducers, have been used to emit ultrasound energy which is applied to anatomical tissue by positioning the ultrasound emitting members adjacent or in contact with the tissue or by coupling the ultrasound emitting members to the tissue via an acoustic coupling medium. By focusing the ultrasound energy at one or more specific focusing zones within the tissue, thermal effects can be confined to a defined location, region, volume or area, and such location, region, volume or area can be remote from the ultrasound emitting member.
With the use of high intensity focused ultrasound (HIFU), one or more focusing zones at or within a designated target location, region, volume or area within a larger mass, body or area of anatomical tissue can be subjected to high intensity ultrasound energy while tissue surrounding the target area is subjected to much lower intensity ultrasound energy. In this manner, tissue at the target area can be heated to a sufficiently high temperature so as to cause a desired thermal effect such as tissue damage, ablation, coagulation, denaturation, destruction or necrosis while tissue surrounding the target area is not heated to damaging temperatures and, therefore, is preserved. Heating of tissue at a target location, volume, region or area to an ablative temperature creates an ablative lesion in the tissue at the target location, volume, region or area that is desirable in the treatment of various medical conditions, disorders or diseases. For example, the lesion may remain as tissue having altered characteristics or may be naturally degraded and absorbed by the patient""s body and thusly eliminated such that the remaining body, mass or area of tissue is of smaller volume or size due to the absence of the ablated tissue.
The use of high intensity focused ultrasound to eliminate tissue or to alter the characteristics of tissue at a target location, volume, region or area within a larger mass, body or area of anatomical tissue presents many advantages including minimization of trauma and pain for the patient, elimination of the need for a surgical incision, stitches and exposure of internal tissue, avoidance of damage to tissue other than that which is to be treated, altered or removed, lack of a harmful cumulative effect from the ultrasound energy on the surrounding non-target tissue, reduction in treatment costs, elimination of the need in many cases for general anesthesia, reduction of the risk of infection and other complications, avoidance of blood loss, and the ability for high intensity focused ultrasound procedures to be performed in non-hospital sites and/or on an out-patient basis.
Various devices and/or methods for treating anatomical tissue with ultrasound have been proposed as represented by U.S. Pat. No. Re. 33,590 to Dory, U.S. Pat. No. 3,990,452 to Murry et al, U.S. Pat. No. 4,658,828 to Dory, U.S. Pat. No. 4,807,633 to Fry, U.S. Pat. No. 4,858,613 to Fry et al, U.S. Pat. No. 4,951,653 to Fry et al, U.S. Pat. No. 4,955,365 to Fry et al, U.S. Pat. No. 5,033,456 to Pell et al, U.S. Pat. No. 5,036,855 to Fry et al, U.S. Pat. No. 5,054,470 to Fry et al, U.S. Pat. No. 5,065,761 to Pell, U.S. Pat. No. 5,080,101 to Dory, U.S. Pat. No. 5,080,102 to Dory, U.S. Pat. No. 5,117,832 to Sanghvi et al, U.S. Pat. No. 5,134,988 to Pell et al, U.S. Pat. No. 5,143,074 to Dory, U.S. Pat. No. 5,150,711 to Dory, U.S. Pat. No. 5,150,712 to Dory, U.S. Pat. No. 5,158,070 to Dory, U.S. Pat. No. 5,222,501 to Ideker et al, U.S. Pat. No. 5,267,954 to Nita, U.S. Pat. No. 5,269,291 to Carter, U.S. Pat. No. 5,269,297 to Weng et al, U.S. Pat. No. 5,295,484 to Marcus et al, U.S. Pat. No. 5,304,115 to Pflueger et al, U.S. Pat. No. 5,312,328 to Nita et al, U.S. Pat. No. 5,318,014 to Carter, U.S. Pat. No. 5,342,292 to Nita et al, U.S. Pat. No. 5,354,258 to Dory, U.S. Pat. No. 5,380,274 to Nita, U.S. Pat. No. 5,391,197 to Burdette et al, U.S. Pat. No. 5,397,301 to Pflueger et al, U.S. Pat. No. 5,409,002 to Pell, U.S. Pat. No. 5,417,672 to Nita et al, U.S. Pat. No. 5,431,621 to Dory, U.S. Pat. No. 5,431,663 to Carter, U.S. Pat. No. 5,447,509 to Mills et al, U.S. Pat. No. 5,474,530 to Passafaro et al, U.S. Pat. No. 5,492,126 to Hennige et al, U.S. Pat. No. 5,501,655 to Rolt et al, U.S. Pat. No. 5,520,188 to Hennige et al, U.S. Pat. No. 5,542,917 to Nita et al, U.S. Pat. No. 5,620,479 to Diederich, U.S. Pat. No. 5,676,692 to Sanghvi et al, U.S. Pat. No. 5,728,094 to Edwards, U.S. Pat. No. 5,730,719 to Edwards, U.S. Pat. No. 5,733,315 to Burdette et al, U.S. Pat. No. 5,735,280 to Sherman et al, U.S. Pat. No. 5,738,114 to Edwards, U.S. Pat. No. 5,746,224 to Edwards, U.S. Pat. No. 5,762,066 to Law et al, U.S. Pat. No. 5,800,379 to Edwards, U.S. Pat. No. 5,800,429 to Edwards, U.S. Pat. No. 5,800,482 to Pomeranz et al, U.S. Pat. No. 5,807,308 to Edwards, U.S. Pat. No. 5,817,049 to Edwards, U.S. Pat. No. 5,823,197 to Edwards, U.S. Pat. No. 5,827,277 to Edwards, U.S. Pat. No. 5,843,077 to Edwards, U.S. Pat. No. 5,871,524 to Knowlton, U.S. Pat. No. 5,873,845 to Cline et al, U.S. Pat. No. 5,873,902 to Sanghvi et al, U.S. Pat. No. 5,879,349 to Edwards, U.S. Pat. No. 5,882,302 to Driscoll, Jr. et al, U.S. Pat. No. 5,895,356 to Andrus et al, U.S. Pat. No. 5,928,169 to Schxc3xa4tzle et al and U.S. Pat. No. 5,938,608 to Bieger et al.
In particular, focused ultrasound ablation devices used to thermally damage, ablate, coagulate, denature, cauterize, necrotize or destroy a target volume of tissue are exemplified by U.S. Pat. No. Re. 33,590 to Dory, U.S. Pat. No. 4,658,828 to Dory, U.S. Pat. No. 4,807,633 to Fry, U.S. Pat. No. 4,858,613 to Fry et al, U.S. Pat. No. 4,951,653 to Fry et al, U.S. Pat. No. 4,955,365 to Fry et al, U.S. Pat. No. 5,036,855 to Fry et al, U.S. Pat. No. 5,054,470 to Fry et al, U.S. Pat. No. 5,080,101 to Dory, U.S. Pat. No. 5,080,102 to Dory, U.S. Pat. No. 5,117,832 to Sanghvi et al, U.S. Pat. No. 5,143,074 to Dory, U.S. Pat. No. 5,150,71 to Dory, U.S. Pat. No. 5,150,712 to Dory, U.S. Pat. No. 5,295,484 to Marcus et al, U.S. Pat. No. 5,354,258 to Dory, U.S. Pat. No. 5,391,197 to Burdette et al, U.S. Pat. No. 5,431,621 to Dory, U.S. Pat. No. 5,492,126 to Hennige et al, U.S. Pat. No. 5,501,655 to Rolt et al, U.S. Pat. No. 5,520,188 to Hennige et al, U.S. Pat. No. 5,676,692 to Sanghvi et al, U.S. Pat. No. 5,733,315 to Burdette et al, U.S. Pat. No. 5,762,066 to Law et al, U.S. Pat. No. 5,871,524 to Knowlton, U.S. Pat. No. 5,873,845 to Cline et al, U.S. Pat. No. 5,873,902 to Sanghvi et al, U.S. Pat. No. 5,882,302 to Driscoll, Jr. et al, U.S. Pat. No. 5,895,356 to Andrus et al, U.S. Pat. No. 5,928,169 to Schxc3xa4tzle et al and U.S. Pat. No. 5,938,608 to Bieger et al. The focused ultrasound ablation devices are used to ablate various areas in or on the bodies of patients including the brain, prostate, heart, urethra, blood vessels, deep seated tissue and tumors, liver, kidney, skin, breast, stomach and pancreas.
Prior focused ultrasound ablation devices have been designed to access anatomical sites at which ultrasound emitting members of the devices must be placed in order to ablate designated target areas. For example, some prior focused ultrasound ablation devices, of which U.S. Pat. No. Re. 33,590, U.S. Pat. Nos. 4,658,828, 5,080,101, 5,080,102, 5,150,712 and 5,431,621 are representative, are designed as structure for being positioned over and/or attached to a patient""s skull. As another example, some prior focused ultrasound ablation devices have been designed as part of a table or support on which a patient is disposed or as structure positioned over such a table or support as represented by U.S. Pat. Nos. 4,951,653, 5,054,470 and 5,873,845. As a further example, U.S. Pat. Nos. 5,295,484, 5,391,197, 5,492,126, 5,676,692, 5,762,066 and 5,895,356 are illustrative of focused ultrasound ablation devices having ultrasound emitting members carried in, on or coupled to flexible shafts, probes or catheters insertable in anatomical lumens, with the shafts, probes or catheters naturally conforming to the configurations of the anatomical lumens. U.S. Pat. Nos. 5,150,711, 5,143,074, 5,354,258 and 5,501,655 are representative of focused ultrasound ablation devices having portions thereof placed against or in contact with patients"" bodies.
Ablation of anatomical tissue of the head and/or neck in order to reduce or eliminate such tissue in the treatment of various airway related disorders has also been proposed as illustrated by U.S. Pat. No. 5,423,812 to Ellman et al, U.S. Pat. Nos. 5,456,662, 5,514,131, 5,624,439, 5,674,191, 5,707,349, 5,718,702, 5,728,094, 5,730,719, 5,738,114, 5,743,870, 5,743,904, 5,746,224, 5,800,379, 5,800,429, 5,807,308, 5,817,049, 5,823,197, 5,827,277, 5,843,077 and 5,879,349 to Edwards and WO 97/43970. The areas ablated include the soft palate, uvula, tongue, tonsils, adenoids and turbinates. U.S. Pat. No. 5,423,812 relates to electrosurgical stripping of tissue. U.S. Pat. Nos. 5,456,662, 5,514,131, 5,624,439, 5,674,191, 5,707,349, 5,718,702, 5,728,094, 5,730,719, 5,738,114, 5,743,870, 5,743,904, 5,746,224, 5,800,379, 5,800,429, 5,807,308, 5,817,049, 5,823,197, 5,827,277, 5,843,077, 5,879,349 and WO97/43970 disclose RF ablation using tissue penetrating electrodes. U.S. Pat. Nos. 5,707,349, 5,728,094, 5,730,719, 5,738,114, 5,746,224, 5,800,379, 5,800,429, 5,807,308, 5,817,049, 5,823,197, 5,827,277, 5,843,077 and 5,879,349 refer to ultrasound as a possible source of ablative energy.
Ablation devices used to treat anatomical tissue accessible via the nasal and/or oral cavities of patients are typically hand-held devices manually manipulated by a surgeon or other operator to position a portion or portions of the devices adjacent or in contact with anatomical tissue of the patients. U.S. Pat. Nos. 5,423,812, 5,456,662, 5,514,131, 5,624,439, 5,674,191, 5,707,349, 5,718,702, 5,728,094, 5,730,719, 5,738,114, 5,743,870, 5743,904, 5,800,379, 5,807,308, 5,817,049 and 5,879,349 and WO97/43970 disclose hand-held RF ablation devices having elongate shafts, arms, probes or catheters extending from handles and carrying tissue penetrating electrodes. U.S. Pat. Nos. 5,707,349, 5,728,094, 5,730,719, 5,738,114, 5,800,379, 5,807,308, 5,817,049 and 5,879,349 disclose catheters that may be malleable in order to conform to the surface of the tongue. WO97/43970 discloses a catheter having a malleable tip.
The pending patent applications incorporated herein by reference and entitled Methods of Soft Palate Reduction By Thermal Ablation Using High Intensity Focused Ultrasound, Methods of Tongue Reduction By Thermal Ablation Using High Intensity Focused Ultrasound, Methods of Tonsil Reduction By Thermal Ablation Using High Intensity Focused Ultrasound, Methods of Turbinate Or Other Soft Tissue Reduction By Thermal Ablation Using High Intensity Focused Ultrasound, Methods of Skin Rejuvenation By Thermal Stimulation Using High Intensity Focused Ultrasound and Focused Ultrasound Ablation Devices Having Selectively Actuatable Ultrasound Emitting Elements and Methods of Using the Same disclose focused ultrasound ablation devices including ultrasound emitting members carried by elongate handle shafts respectively coupled to handles used by surgeons or other operators to position active faces of the ultrasound emitting members adjacent or in contact with anatomical tissue or structures to effect ablation at various designated target areas in the tissue or structures.
It would be desirable for the configuration of the handle shafts to be selectively adjustable to access various anatomical tissues or structures from externally of patients"" bodies and/or to orient the active faces in accordance with the locations of the designated target areas. It would be desirable for an individual handle shaft to be capable of assuming various selected configurations while the handle thereof remains in an operative position or orientation for optimum grasping by the surgeon or other operator. In this manner, the handle could be grasped by the surgeon or other operator in the same way each time the focused ultrasound ablation device was used, while the handle shaft could be disposed in different selected configurations relative to the handle for each use. It would be desirable for selective adjustment of the configurations of the handle shafts to be obtainable with minimal effort and time expended by the surgeon or other operator and without complex operational steps. It would also be desirable for the handle shafts, once adjusted to selected configurations, to effectively maintain the selected configurations without further intervention by the surgeon or other operator so that the active faces remain properly positioned during the ablation procedures.
Accordingly, the need exists for a hand-held focused ultrasound ablation device having a handle shaft that is selectively adjustable, with minimal time and effort by a surgeon or other operator, in order to adapt the handle shaft for accessing anatomical tissue or structure of a patient from a remote location, typically external of the patient""s body, and/or to properly orient an active face disposed at a distal end of the shaft so that the active face may be positioned at a desired location on the tissue or structure. A need exists for a focused ultrasound ablation device having a malleable handle shaft capable of being selectively shaped to avoid anatomical obstacles when introduced in an anatomical passageway used to access an internal operative site. The need further exists for a focused ultrasound ablation device having a selectively adjustable handle shaft by which a single focused ultrasound ablation device can be adapted to effect ablation at various anatomical areas including, for example, the soft palate, tongue, tonsils, turbinates or other soft tissue and skin. There is also a need for a focused ultrasound ablation device having a malleable handle shaft by which an active face of the device can be selectively oriented horizontally, vertically, transversely and/or at various angles, thereby increasing the areas of potential use for the focused ultrasound ablation device. An additional need exists for a focused ultrasound ablation device having a malleable handle shaft which, upon being manually placed in a selected configuration by a surgeon or other operator, maintains the selected configuration without further intervention by the surgeon or other operator.
Accordingly, it is a primary object of the present invention to overcome the various disadvantages of prior focused ultrasound ablation devices.
It is also an object of the present invention to provide a hand-held focused ultrasound ablation device having an ultrasound emitting member at a distal end of a malleable handle shaft by which the orientation of the ultrasound emitting member can be selectively adjusted.
Another object of the present invention is to provide a hand-held focused ultrasound ablation device having an ultrasound emitting member at a distal end of a malleable handle shaft allowing the configuration of the handle shaft to be selectively manually adjusted for accommodation in an anatomical passageway through which the handle shaft is to be introduced, from external of a patient""s body, in order to position the ultrasound emitting member at an operative site in the patient""s body.
A further object of the present invention is to selectively shape a malleable handle shaft, coupled to an ultrasound emitting member, so that an active face of the ultrasound emitting member is positioned at a desired location on anatomical tissue within which an ablative lesion is to be formed with ultrasound energy emitted by the ultrasound emitting member.
An additional object of the present invention is to facilitate the performance of high intensity focused ultrasound ablation procedures in various anatomical areas with the use of a single focused ultrasound ablation device.
It is also an object of the present invention to provide a focused ultrasound ablation device having a malleable handle shaft capable of axial and/or torsional adjustment.
Yet another object of the present invention is to selectively shape a malleable handle shaft of a focused ultrasound ablation device to assume various different configurations for different procedural uses while a handle coupled to the shaft is in the same orientation for each procedural use.
The present invention also has as an object to permit selective adjustment of the configuration of a handle shaft of a focused ultrasound ablation device so that an active face of an ultrasound emitting member coupled to the handle shaft can be selectively oriented to assume various vertical, horizontal and transverse positions, or combinations thereof, at various angles.
Some of the advantages of the present invention are that the need for mechanical steering devices is eliminated, the handle shaft is not limp and shapeless but, rather, has sufficient rigidity thereto to facilitate handling and use, the handle shaft, once placed in a selected configuration, maintains the selected configuration without further interaction therewith, the handle shaft can be shaped to assume configurations corresponding to the configurations of various anatomical passageways such as the oral cavity and nasal passageways, the handle shaft can be configured to avoid anatomical tissues or structures in the anatomical passageways through which the handle shaft is to be introduced in order to access operative sites from remote locations, such as externally of patients"" bodies, tissues or structures in the anatomical passageways may not have to be retracted, manipulated or otherwise interfered with since the handle shaft is capable of being configured to avoid or circumvent such tissues or structures, the handle shaft has sufficient rigidity to allow the active face to be held against a tissue surface via a handle proximally coupled to the handle shaft, the configurations of the handle shaft can be adjusted prior to or during use with minimal effort and time expended by the surgeon or other operator and without the need for highly specialized skill and expertise, the configuration of the handle shaft can be adjusted without damage to mechanical components within the handle shaft, the force needed to shape the handle shaft can be minimized, the active face can be made to assume virtually any desired angle, the handle can be grasped and held by surgeons or other operators while in the same orientation or position for consistency of use even though the handle shaft and/or active face may be in various different orientations or configurations, the focused ultrasound ablation device does not have to be customized for use in a specific area of the body, and the focused ultrasound ablation device can be provided ag a standardized instrument capable of being used in or on a wide variety of areas of patients"" bodies.
These and other objects, advantages and benefits are realized with the present invention as generally characterized in a focused ultrasound ablation device comprising an ultrasound emitting member, an elongate handle shaft having a distal end at which the ultrasound emitting member is disposed and a handle coupled to a proximal end of the handle shaft. The ultrasound emitting member emits ultrasound energy and causes the emitted ultrasound energy to be focused in front of an active face of the ultrasound emitting member. The handle shaft is malleable to permit longitudinal and/or torsional adjustment or shaping of the handle shaft for accommodation in an anatomical passageway through which the handle shaft is to be introduced to position the ultrasound emitting member at a selected operative site and/or to selectively orient the active face to contact anatomical tissue at the operative site. Via adjustment of the handle shaft, the active face can be oriented to face upwardly, downwardly, laterally or forwardly of the ablation device or at various positions therebetween. By adjusting the handle shaft, ultrasound energy is emitted from the ultrasound emitting member in a desired direction relative to the handle shaft and/or the handle so that the ultrasound energy is focused at a desired target area in the anatomical tissue.
A method of thermally ablating anatomical tissue of a patient is generally characterized by the steps of manually shaping a malleable handle shaft of a focused ultrasound ablation device so an active face of an ultrasound emitting member carried at a distal end of the handle shaft is oriented to contact anatomical tissue at an operative site, positioning the active face against the tissue at the operative site, emitting ultrasound energy from the ultrasound emitting member, focusing the ultrasound energy at a focusing zone contained in target area within the anatomical tissue and located a predetermined distance in front of the active face, and heating the tissue at the target area with the focused ultrasound energy to form a lesion.
Other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings, wherein marked parts in each of the several figures are identified, by the same reference characters.